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CompletedNCT03382054Updated Jun 15, 2023

Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment

An observational study in Frailty, Surgery and Older Patients, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
25,000
Ages
70 Years and older
Sex
All
01

Study summary

Frailty is prevalent in older adults and may be a better predictor of post-operative morbidity and mortality than chronological age. Preoperative risk factors and physiological reserves were assessed on patients more than 70 years old who are scheduled for surgery under general or regional anesthesia. The aim of this retrospective analysis was to examine the impact of relevant geriatric assessments on adverse outcomes in older surgical patients.

Read the detailed description

The goal of this study is to analyze the effect of frailty status on postoperative outcomes. These include postoperative complications (only ICD-10 coded diagnoses), length of hospitalization (ward/ICU), disposition, and survival. The project will also attempt to find synergism between a positive frailty status and common medical conditions (e.g. diabetes, congestive heart failure, coronary artery disease, dementia, and kidney disease), as well as anesthesiological and surgical processes (e.g. duration and type of anesthesia, surgical risk, and surgical discipline). Different assessment tools will be analyzed regarding their predictive power and clinical practicability. This should help improve preoperative risk assessment and allow for the multidimensional (physical, cognitive, social) identification of relevant frailty characteristics in the perioperative setting. All outcome parameters, including admission and discharge periods, will be collected using coded information from our hospital database. There will be no follow-up measurements after hospital discharge.

02

Conditions studied

  • Frailty
  • Surgery
  • Older Patients

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03

In context

Frailty

1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.

This study's enrollment of 25,000 is above the median of 211 across 503 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Male and female patients with age 70 years and above scheduled for surgery

Eligibility criteria

Inclusion Criteria:

  • Male and female patients with age 70 years and above scheduled for surgery in the Department of Anesthesiology and Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
25,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Older robust surgical patients

    Male and female patients with age 65 years and above scheduled for surgery, which are robust according to Fried's Modified Frailty Score.

  • Older pre-frail surgical patients

    Male and female patients with age 65 years and above scheduled for surgery, which are pre-frail according to Fried's Modified Frailty Score.

  • Older frail surgical patients

    Male and female patients with age 65 years and above scheduled for surgery, which are frail according to Fried's Modified Frailty Score.

06

What researchers measure

Primary outcomes

  1. Postoperative complications

    ICD-10 coded diagnoses for the hospitalization

    Time frame: 06/2016-12/2022

Secondary outcomes

  1. Duration of Hospital stay

    Time frame: 06/2016-12/2022

  2. Duration of Intensive Care Unit Stay

    Time frame: 06/2016-12/2022

  3. Procedures

    The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral

    Time frame: 06/2016-12/2022

  4. Morbidity

    Time frame: 06/2016-12/2022

  5. Ventilation

    Ventilation is measured in hours.

    Time frame: 06/2016-12/2022

  6. Requirements for intensive care unit

    Time frame: 06/2016-12/2022

  7. Intensive care unit scores

    Time frame: 06/2016-12/2022

  8. Disease severity

    Time frame: 06/2016-12/2022

  9. Postoperative Delirium

    Delirium is measured with validated delirium scores.

    Time frame: 06/2016-12/2022

  10. Mortality

    Mortality is measured in hospital.

    Time frame: 06/2016-12/2022

  11. Medical costs

    Costs incurred during hospitalization

    Time frame: 06/2016-12/2022

  12. Physiotherapy

    Physiotherapy is measured by Physiotherapists support.

    Time frame: 06/2016-12/2022

  13. Nutritional therapy 1

    Nutritional consultations

    Time frame: 06/2016-12/2022

  14. Nutritional therapy 2

    Feeding

    Time frame: 06/2016-12/2022

  15. Post - intensive care syndrome

    Post - Intensive care syndrome is measured by a cluster of symptoms that are unique to the Intensive care unit environment.

    Time frame: 06/2016-12/2022

07

Study locations

1 site
  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
    Berlin, 13353, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03382054
Responsible party
Claudia Spies (Clinical director of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charite University, Berlin, Germany) — Principal investigator
First posted
Dec 22, 2017
Start date
Jun 1, 2016
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Jun 15, 2023

Study contacts

Claudia Spies, MD, Prof.
study director · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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